The people's blog site where news, ideas, job opportunities and what's been heard on the street can be discussed in a professional manner.

Tuesday, August 2, 2011

Is Technology Distracting the Art of Surgery?

There's an opening scene in the documentary It Might Get Loud, where Jack White, the infamous maniacal and passionate guitarist is driving down a country road in Franklin Tennessee with l'il Jack in the back seat and states, "technology is a big destroyer of emotion and truth. Obviously it makes it easier for you to get home sooner, but it doesn't make you more creative as a person. That's the disease you have to fight in any creative field, ease of use. "

On July 31st, the Courier Journal reported that two Norton Healthcare surgeons form Louisville, Kentucky were criticized by The Spine Journal (TSJ) for allegedly under reporting or failing to mention side effects from INFUSE and Amplify. TSJ said that John Dimar II and Steven Glassman were among surgeons that under reported or failed to mention side effects including cancer, male sterility, unwanted bone growth, and nerve damage in 13 papers published between 2000 and 2010 that were sponsored by Minneapolis based Medtronic. The 13 papers in question concluded that INFUSE and Amplify were at least as safe as bone grafts.

TSJ is the official journal of the North American Spine Society (NASS). In a statement NASS concludes that, " it harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research, concluding that the adverse effects were 10 to 50 times greater than what was reported. Three of the thirteen papers were authored by Dimar II and Glassman, whom declined to be interviewed for the article.

The paper in question was authored in 2009 by the two Louisville spine surgeons and four co-authors regarding a 463 patient trial of Medtronic's Amplify, saying the study failed to stress a link to cancer. Granted Dimar II and Glassman were each paid royalties of $2.4 million dollars, but that was for top selling products that they had helped to develop. Several years ago Medtronic paid a fine of $40 million dollars to settle a claim that they had paid surgeons to use their products. The obvious argument will be made by some of our bloggers that this is old news. Contrary to those beliefs, one must ask the question, has innovation in technology taken away the art of surgery? Innovation and emerging technologies are important. But, where does one draw the line when it comes to a craft like surgery? Have training programs and surgeons gotten away from what made the art of surgery a great profession, the ability to transfer knowledge to one's hands and potentially enhance the patient's quality of life? Has BMP become the victim? Is BMP the really the root cause of the controversy that surrounds Medtronic and its relationships, or is it managing the behaviors inherent to our own human nature? By not being forthright in their past findings, not only are these surgeons performing a disservice to the public, they are leaving a lingering cloud hanging over their reputations? Maybe reputation really doesn't matter or does it?

All one has to do is open a copy of the original INFUSE training manual to understand the concerns that were expressed in the administration of the product. Clearly, there were caveats. Medtronic, as usual, will cooperate with the on going investigation by the Senate Finance Committee by turning over the appropriate documents in question, but in the end will they modify their behavior when a $40 million dollars fine is far less than the profits made on the commercialization of the product? Industry insiders will argue that the FDA and big government are inept at designing an acceptable pathway to commercial use, and at times arguably so, but what happens when there is intent to obfuscate the truth? TSB and its readers do not need to take sides in this ongoing debate, the exercising of orating in a public forum can be left up to those that are the gatekeepers of this profession, the surgeons. It will be interesting to assess the climate at NASS this year, who knows maybe something good will come out of this, or, maybe like Jack White says, it comes down to convenience and ease of use. TSB wants to know is INFUSE the victim or is it the culprit, you be the judge.

87 comments:

True that brother! A neurosurgeon that I have worked with for years just told me today that Globus has offered him a consulting deal for its entire lateral portfolio. According to my doc, they said that they will pay him royalties for every single type of lateral cage that they sell...even the ones that were developed before he came into the fold (ahem...ALL OF THEM!!).

He said that he is turning the deal down for three reasons:

1) Two of his colleagues "down south" just received the same offer. In his words, "how many consulting surgeons can one product-line sustain?"

2) He is concerned about the Synthes/NuVasive lawsuits directed at Globus' lateral product offering. He doesn't think that the deal is worth sullying the relationships he has with other companies that are, shall we say, "less than Globus-friendly".

3) He thinks that it is immoral to receive royalties on products that he had no hand in developing.

I guess this just goes to show that there are still some good docs out there not willing to sell their souls to the devil for the almighty dollar.

Spine 360 is the "KING" of buying bogus ip! Every surgeon using spine 360 implants has a royalty deal. That's how Spine 360 skirts kick back issues. I'd like to see just how much ip they have bought v how much bought ip 360 has actually developed. Any guesses?

However, royalties are possibly obfuscating clinically sponsored research outcomes. This is certainly a troubling trend. In theory, every study is designed with inclusion criteria (Healthy, 40 something male, non-smoker...) that should preclude undesirable outcomes. That's one thing; but, failing to report "side effects" is certainly becoming a troubling common link between Infuse, Amplify, and who knows what other ticking time bombs are out there.

If true, this is reprehensible behavior by a small group of surgeons putting their own monetary gain ahead of thousands, if not hundreds of thousands, of patient's lives.

It always has & always will exist in this business. Especially when surgeons who have gone to college, med school & in most cases completed a fellowship, feel "entitled" to the riches that this industry provides. Especially those coming out of programs where their mentors, in many cases, are the pioneers of setting up big paydays for themselves.

No seriously, who cares about what is going on with Globus. When/if something happens to them, then we all can talk about it. As of right now, it has nothing to do with this article and nothing to do with the question at hand.

That "small group of surgeons" in Louisville was ranked #3 nationally for spinal fusions on Medicare patients over a 4 year period (did I say in Louisville?). Just another piece of a very ugly puzzle. I'm not sure that technology is distracting the art of surgery, but greed on both sides of the aisle certainly is.

So....the allegation is that they reported the cancer rate in a table, but did not specifically discuss it in the text of the article. Somehow this was caused by them receiving royalties on a different product.

Wow. That's some weak &^%$. Sounds more like the typical stale anti-corporate Marxist garbage we hear from the old hippy politicos than a serious medical ethics issue.

People - wake up and read the papers for yourselves already. What, did you get duped by skipping the paper & just reading a little bit of the "conclusions" section? Just because you are intellectually lazy, does not mean somebody else is crooked.

All this criticism of Medtronic. In my area Depuy is the company with all the Paid Consultants. They own these surgeons. The surgeons are told what to do and how much to do it. They have to comply or else lose their monthly checks.

If you're a Globus rep and that close to the fire, then why the hell would you care what everyone's thoughts on this board are as it relates to your company going public?

Shouldn't you be asking that question to your fearless leadership team in Audobon, PA?

Anyway, since you're looking for opinions, here's mine: Stop wasting your time there and hoping that your 10,000 stock options are going to materialize into something. Take a look at Nuvasive's stock today trading at $26 & change and then realize what a far more solid company Nuvasive is than Globus. That said, if NUVA stock is slogging in the mid $20's,, what are the odds that Globus' value is even half that?

Is infuse a victim or a culprit? Those who were around during the cage rage asked the same question. Is Infuse bad? Like all things, if used poorly or for the wrong reasons, certainly it is. Is there risk, yes, but again when used at times the risk is higher than not using it, it's pretty hard to say it's a bad thing. It those cases, it is the victim.

But is it the culprit. Though only an opinion, it's one I have heard more than ever in the past year. Too many have come to rely on it. What are those who rely on it heavily going to do? They will actually have to pay considerably more attention to interbody prep, not only the shape, size and fit of interbody products, but the stability to hold the anterior column in position while all heals. Complications are real with BMP, but rare enough that adopters continue to use it, too often without regard to potential outcomes.

So, it is a culprit as well, it does make bone, sometimes a bit too well. It has become more culprit than victim as surgeon have come to rely on it, take short cuts because of it, and are now faced with having to learn how to do a better job without it.

Though a bit of stretch, it could actually spark innovation, a revisit of interbody devices that do more than take up space, made of materials with osteoconductive properties, etc. And, maybe, just maybe, will lead to better outcomes than we have seen since the advent of the cage rage.

Si Bone is extremely complex in trying to visualize in 3d and using two c arms on just how to place those titanium pins. I have been in labs where both the "instructor" and atendees have disagreed on orientation and placement. Seems to be a straight up learning curve..but maybe it does work? Dunno.

9:25 Preliminary response from OIG/DOJ is due by August 12th regarding request from Senator Grassley's committee to investigate and provide guidance on legality of PODs. Don't expect any action from Senate unless DOJ comes back saying that all PODs are legal. The letter to the OIG was clear that action was expected fom the DOJ if their reveiw indicated PODs weren't legal. Of interest to readers here will be how they respond to the Senate's statement that guidance without enforcement is useless.

Bravo DMOS! A return to thorough disc prep which is well established in the literature (the art of surgery) as necessary for good fusion outcomes by-and-large fell out of favor when surgeons came to believe that all they needed to do was pack in a little BMP and whala, fusion. Let’s see…sterioids or a good gym work out….I think surgeons in big numbers are going to return to gym when it comes to fusion disc preparation.

the US is out of Money nearly bankrupt like so many of it's states- our stock market is about to collapse. The federal government doesn't have the time or resources to worry about PODs. Congress has much bigger problems than PODs.

No Cooke isn't a crook. I'm sure not showing a profit had a lot to do with the lay offs BUT, if the people who got shit canned were pulling their weight they would still have jobs? There were some real worthless idiots in play - Pat Klinger and all of his cronies to name a few.

How in the world do you consider Nuvasive a mid-major? They are the 4th largest spine company in the country - 3rd largeset if you count Depuy/Synthes as one... ??? Medtronic, Synthes/Depuy, Nuvasive! Mid-major???

"These data demonstrate that a tissue-engineered IVD can be implanted into the caudal spine, remain in place, withstand the mechanical loads, and survive and produce an integrated and mechanically functional ECM similar to the native IVD," the authors write.Doubtful in humans. Rats' spines do not have identical, weight bearing forces.Engineered tissue will be quite expensive.The Genzyme autologous cartilage cells were costly, and did not often "take", experienced biomechanically weak attachments.Will insurers pay? No way. The trend is to deny expensive surgical treatment. Here's your walker and your Meds, now go home on disability and be on foodstamps but no more Medicare for you.

4:23, hey I was the one that @ 4:11. My thoughts were the same as yours. It's one thing to implant in a mouse but as you pointed out, could the human load that compresses the spine while in felx/exten, be just too much load for something man made and engineered like this tissue is??

BFreeman

I only post this for comments, as what else do we has sales professionals have to be excited about in the near future to carry in our bags? another cervical plate, another dynamic wannabe system, another ALIF stand alone device?? Come on, you have to be serious.

Lets get real here and talk about what we see, hear and think will be the next breakthrough product or technologies instead of will Globus go public or will Nuvasive go bust, or will POD's be just another fade! Will this really benefit the patient, our customers or the end users??

Bigger picture. Macro. What's happening today with equities and Europe financial troubles may signal the beginning of another worldwide credit freeze and market crash. See 2008 for details, times two.Meaning companies without bona fide operating profits will be squeezed to generate operating capital. Meaning less viability for smaller companies, some will go under or be acquired. Mergers. Consolidation, retrenchment. See Depuy Synthes for openers. See layoffs and manpower cuts at Medtronic and Alphatec. Not the time in the business cycle to launch new technology unless it is proven to save money elsewhere. Better outcomes? Who cares!

The bigger picture is survival through consolidation and direct representation. With increased oversight, as well as price erosion, the new model will be to eliminate distributors, scale back sales forces, and make all field personnel direct. J and J will phase out distribution as it integrates Synthes. Medtronic will follow. Compensation will drop off and a new breed of "pharma" reps will gladly detail products for 100K per year. Hospitals will be responsible for training their staff on the equipment as they have historically done with other fields.

Simple ACDFs , PLIFs and scolis will be ok. The same poorly trained afternoon relief techs will still struggle with MIS and complex trauma. Three hour cases become eight hour cases. Patient care will suffer. Surgeons get frustrated and are forced into simpler systems. Innovation stops. Reps who take the lower paying jobs will be worth every ( less) penny sadly. Hospitals no longer care, they are not judged on outcomes. They just see themselves as risky hotels who will never see most of their customers again, so can get by with restricting to only the cheapest cost inputs.

so Technology does stop distracting surgeons from the art of surgery. the spine industry contracts inward, with the gravitational force of a black hole. Less trained surgeons in surgery centers will see a large drop off of patients as denials increase. Patients start finding their way back to large academic institutions that are efficient in managing spine care. True spine specialists will have the same, or more volume. The outliers will see their gravy train dry up.. But on the bright side, the surgery that is done will be done by better qualified surgeons who know the art of surgery is more important than contrived technology used to overcome poor skills and justification of billing codes. Patients will ultimately win. as Spinedoc said recently, reps go the way of buggy whip makers---

No, patients will not necessarily ultimately win. Their treatment, if they get it, will be delayed. They may get cheaper, quicker to fail, generic implants. They may experience greater blood loss and time under anesthesia and damage from positioning while poorly paid, less experienced reps waste time struggling to find unfamiliar instruments in their trays. Eventually things will settle out, but at a lower level of options. Everyone will get only peas, and like it.

6:50 don't be a chicken little!! Doomsdayers screamed generic drugs would devastate health care. Big Pharma lobbied against them. The sky never fell. Delaying treatment? Maybe the delay will allow some to follow through with weight loss and conservative care vs. the scalpel. And the funneling of patients back to larger institutions who are specialized in managing these pathologies will result in less blood loss and time under anesthesia. But since your continued high compensation is on the line, let's continue to hope for the same over utilization of funds such as the ridiculous number of "injections" done by non spine trained surgeons in "surgery centers"

We are not arguing. The funneling of patients to larger institutions who can safely deal with the lowered quality of support, will result in fewer patients being offered high quality surgical care. Already, the slower rural hospitals here have stopped offering spine surgeries. Good thing, they had lowered their costs through capitation so low they were using schlock products, bad support reps, and they were experiencing disaster cases and lawsuits.Private pay.... Yes you will get good surgeons and support. Insurance? More likely to be denied. Medicare? Ha ! You have to see th future, it's easy because it's already happening. Yes, injections are welcome by all, the facilities make money, the docs make money, the insurance cos make money... Its just another pain med, like the trend says.....

Alphatec sales are up but their earnings are down. I figured buying their instruments from China would have helped the bottom line. Also, a healthy company does not cut 10% of the employees. I think they are going to run lean to boost earnings and sell that POS of a company.

Bleed this, NUVA is just fine. While other companies are laying off and consolidating, Nuvasive's hiring. While other companies are scaling back and not taking risks, Nuvasive is growing. While other companies are distancing from the core issues, Nuvasive has stood behind the surgeons and are pounding the pavement with patient ambassadors about the benefits and good things happening in spine surgery. The Stock price only represents the current (daily) 'perception' of a company, based on numbers and earnings. The true value of a company like Nuvasive is behind the numbers. Why has the company grown from nothing to #3 in Spine? Surgeon education, innovation and patient advocacy.

Oh and 6:12, how about Zimmer trading at $56, or Orthofix is $40. How you like them apples?

Afraid you clunked into a dead-end there with that attempted comparison to Zimmer and OFIX, which are down only 17% and 9% in a bad market spell.The comparison Actually makes NUVASIVE look worse....Is something going wrong under the surface to make investors want to bail?

again, 6:12 and 8:52 show the maturity on this blog! Do you little boys have nothing better to do thing try to show us who d*ck is bigger? I REALLY think NO ONE other than investors or you two care one bit about Nuvasive's stock or will Globus go public. This is where the business has gone. Instead of talking about where this moarket is heading or what new IP might be coming out, you stoop to one up each other. Great job!

WOW,, brilliant response, truly brilliant. As for asking me how I like them apples, here is my response:

Neither Zimmer nor Orthofix are trading at those levels becasue of their spine divisions. They're trading at those levels because they are diversified across other specialities.

On that note, honestly not really sure what point you were trying to make.

As for your comment "The Stock price only represents the current (daily) 'perception' of a company, based on numbers and earnings. The true value of a company like Nuvasive is behind the numbers". HUH??

You contradict yourself in your own commment,, AGAIN, brilliant.

As for whatever "perception" the market has, I can say this,, rarely is the market wrong & for a company who is currently trading at 52 week lows, as well as just $10 over where it IPO'ed in 2005, Nuvasive must not be perceived all that well by those who cover this industy & know it inside & out. Otherwise, if Nuvasive had so much of an upside as you want to boast they do, I would certainly expect those in the investment community to be on board & riding along; not unloading this thing like there's no tomorrow.

Nuvasive is a house of cards and investors have finally caught on. As an investor it was worth the risk when growing 35% or more with lateral exclusivity. Now when only growing 11% and no strategic advantage there are better places to put your investment $s. Neuromonitoring cash cow franchise is almost finished as well. Hospitals no longer willing to spend a $1,000 premium and surgeons no longer willing to assume all liabilty.

Don't ever let 360 come out for a meet and great w one of your surgeons. Carter Buton and DJ came out to meet w me and one of my busy surgeonsover dinner the very next morning Carter and DJ were in my surgeons office offering a roylty deal for his business - they were offering to buy "IP" as long as my guy would do business. To top it all off they were going to cut me out as a rep a d reduce my commissions to 5 points a d use the rest of my commissions to fund the phony "IP" buy out deal. Bunch of snakes!!!!! Luckily my surgeon is loyal and ran them off! Ive since been told that is standard MO for Carter and DJ

So has integra and 360. Trust me I live in Austine and very close to the source who knows people at both companies and those people talk to people at the top. Integra has all 360's files and records too. So yeah basically it's practically a done deal -

i am new and just found this board - should i take an associate role with lanx or medtronic? fortunately, in these tough times, i have choices. who should i work for ? worked in pharma for 2.5 years and didnt cut it. was told i was perfect for these 2 companies. both called and both made offers after a few interviews.

11:28 let me understand this...you "worked" in pharma for 2.5 yrs and "didnt cut it". I would say maybe find something other than sales my friend! If you could'nt cut it in Pharma, which is a FAR CRY to Medical Device Sales, then you have a long road ahead of you!My question is why didnt you "cut it"? And what value does Lanx or MSD see in you? I am not attacking you, just the way you phrased it "didnt cut it". Was it pharma or you just couldnt cut it? Pharma is a joke, so dont even compare the two.And to answer your question which one you should run with...thats like saying who's a better hitter in baseball, Mark Mcguire or Roger Clemons

Given the lesser of two evils I would say go with Medtronic. They have a good training program and are a good way to break into the industry. Just don't expect to have much of a future there. They're just looking for cheap company guys to grind it out. That said, they are the market leader and Medtronic will at least look good on your resume when you decide to advance your career.

Lanx is a total joke to be avoided at all costs. If it wasn't for the fact that they got lucky with one product, they would be done by now. Having Lanx on your resume is scarcely better than having a felony.

Do you realize we are all doomed. Our industry is hiring ex-pharma reps that didn't even cut it selling boner pills! Historically pharma reps were not considered to have the skills needed for spine sales. This is proof we will be glorified coffee delivery people driving Chevy impala's.....if we do really good we will get a Subaru Outback. FML!

ISTO is one company with a bright future. Disc regeneration is a game changing technology if it proves out in the clinical trials.

Infuse has made surgeons lazy. If the surgeon is a good carpenter, and gets good bleeding bone, many products will work as an autograft extender. Medtronic is in serious trouble, and they won't simply get off this time with a meaningless $40 million fine.

Alphatec is heading for a crash they laid off the best manufacturing person we have had so far. No experience left in Mfg. Not sure who made that call but some with no clue! Mr Ryan? New products complex costing more than products they are replacing and they expectthem to sell!! we do not pay our bills either vendors unhappy always calling A.P.

TSB...how about a discussion around why there aren't generics in Orthopedics? I think its ridiculous that pharma spends enormous amounts to get a product to market and is only given 10 years of patent life and device has only to prove itself based on a predicate device and takes less than a year to launch and is given 17 years patent life. Device (ORTHO ) then has no worries about generics after patent expiration. Seems wrong to me